The first vaccine for people with coeliac disease has begun phase 2 testing after a decade of development

A vaccine that could enable people with coeliac disease to safely consume gluten has begun phase 2 testing in the US, Australia, and New Zealand after more than a decade of development.

A promising new vaccine that could be used to treat those with coeliac disease to allow them to safely consume gluten has begun phase 2 testing in the US, Australia and New Zealand to evaluate its efficacy after results from several phase 1 trials showed that the immune system-modifying treatment, called Nexvax2, is safe and tolerable.

Nexvax2 works by reprogramming T-cells so that can no longer attack certain amino acid sequences called peptides which exist within the proteins that make up gluten by repeatedly exposing the body to modified forms of three of these particular peptides.

Encouragingly, results from phase 1 revealed that in approximately 80 to 90%, the patient’s inflammatory response to gluten occurs if the coeliac patient is a carrier of the HLA-DQ2.5 gene as this particular gene is able to create a recognition protein to inform the bodies T-cells to flag harmless gluten peptides as dangerous.

However, whilst the vaccine trial has achieved a level of success for people with coeliac disease, the vaccine will not work for patients with non-gluten sensitivity.

According to a statement from Leslie Williams, the CEO of ImmusanT, the company behind Nexvax2:

“The initiation of our Nexvax2 Phase 2 trial is significant for patients who suffer from celiac disease, a condition affecting approximately 1% of the global population. This trial is designed to demonstrate protection against inadvertent exposure to gluten, but the ultimate goal is to develop Nexvax2 as a treatment that will allow patients to return to an unrestricted diet.”

ImmusanT researchers are looking for 150 coeliac patients across the three countries to take part in the trials to test the viability of the vaccine. Participants will receive 32 total injections of Nexvax2 or placebo before they are asked to undergo masked gluten food challenges where they will be given food to eat without being told if it contains gluten or not.

“This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet,” Dr Tye-Din, a gastroenterologist at the Royal Melbourne Hospital and head of celiac research at the Walter and Eliza Hall Institute, stated. “The gluten-free diet is the only current treatment for coeliac disease, but it is onerous, complex and not always effective. Even the most diligent patients can suffer the adverse effects of accidental exposure.”